Ignite Creation Date:
2024-05-05 @ 9:37 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00925119
Status:
TERMINATED
Last Update Posted:
2019-09-26
First Post:
2009-06-17
Brief Title:
Examining Genetic Influence on Response to Beta-Blocker Medications in People With Type 2 Diabetes
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Uncoupling Protein Polymorphisms and Cardiometabolic Responses to Beta-Blockers
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Beta-blockers are medications used to treat cardiovascular disease CVD symptoms including high blood pressure and chest pain People with diabetes who receive beta-blockers may experience adverse health effects but the exact cause of why this happens remains unknown This study will examine the genetic factors that may influence how atenolol a beta-blocker medication affects fat breakdown blood sugar levels and heart function in people with type 2 diabetes
Detailed Description:
People with diabetes who develop CVD have worse health outcomes than people without diabetes who develop CVD Beta-blockers are medications used to treat high blood pressure angina ie chest pain arrhythmias and other CVD conditions While beta-blockers are effective at treating these conditions they may also have damaging effects on cholesterol or glucose levels thereby possibly lessening their ability to prevent CVD events in people with diabetes It is important to identify which patients may not benefit from receiving beta-blocker medications Genetic factors may influence how people respond to beta-blocker medications The purpose of this study is to evaluate the influence of genetic variation on beta-blocker-induced changes in insulin sensitivity fat breakdown and heart function in people with type 2 diabetes
This study will enroll people with type 2 diabetes At a series of up to three baseline study visits participants will have a blood collection a glucose tolerance test an echocardiogram to obtain images of the heart and biopsies of muscle from the thigh and fat from the stomach All participants will then receive atenolol once a day for 8 weeks During Week 1 participants will receive a low dose of atenolol They will then attend a study visit at the end of Week 1 and study researchers will examine how well participants are tolerating the medication If the atenolol is well tolerated the dose will be increased Study researchers will call participants 1 week after any dosage changes to monitor for side effects Blood collection will occur again at a study visit at Week 4 At Week 8 participants will then attend up to three study visits for repeat baseline testing Participants will then be slowly tapered off of atenolol over a 1-week period
This study will enroll people with type 2 diabetes At a series of up to three baseline study visits participants will have a blood collection a glucose tolerance test an echocardiogram to obtain images of the heart and biopsies of muscle from the thigh and fat from the stomach All participants will then receive atenolol once a day for 8 weeks During Week 1 participants will receive a low dose of atenolol They will then attend a study visit at the end of Week 1 and study researchers will examine how well participants are tolerating the medication If the atenolol is well tolerated the dose will be increased Study researchers will call participants 1 week after any dosage changes to monitor for side effects Blood collection will occur again at a study visit at Week 4 At Week 8 participants will then attend up to three study visits for repeat baseline testing Participants will then be slowly tapered off of atenolol over a 1-week period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23HL091120 | NIH | None | httpsreporternihgovquickSearchK23HL091120 |